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Ulthera(TM) Receives First-Ever FDA Clearance to Market Ultrasound

September 16, 2009 |

MESA, Ariz., Sept. 16 /PRNewswire/ — Ulthera, Inc., a therapeutic ultrasound
medical device company serving the $30 billion global aesthetics market, today
announced that the U.S. Food and Drug Administration (FDA) has granted
clearance for the use of its Ulthera(TM) System to achieve a non-invasive
eyebrow lift.

The Ulthera System is considered a first-of-its-kind technology, unprecedented
in the marketplace, and as such underwent a 510(k) “de novo” review by the
FDA.  It is substantially different than other in-office aesthetic devices
because it combines visualization beneath the skin’s surface with non-invasive
delivery of ultrasound energy at depths that enable significant lifting of the
skin. While drawing on the same reliable ultrasound principles that physicians
and patients have trusted for decades, Ulthera’s patented DeepSEE(TM)
technology allows physicians in aesthetics to both see and treat deep below
the skin without surgery. 

“We use imaging to anticipate where the energy will be placed, and then we
deliver small amounts of very productive energy to targeted planes of tissue.
This precision contributes to both safety and effectiveness, and because this
is accomplished without damaging the superficial layers of skin, patients
experience no down time,” said principal investigator Murad Alam, M.D.,
Associate Professor of Dermatology and Otolaryngology and Surgery, and chief
of the Section of Cutaneous and Aesthetic Surgery at Northwestern University’s
Feinberg School of Medicine.

Focused ultrasound energy triggers the body’s natural healing response,
resulting in new and improved collagen support and gradual firming, tightening
and actual lifting of skin tissue over time. Patients receiving an Ultherapy
treatment for a brow lift, for example, report less hooding and laxity of the
eyelid skin and a more “open” look around the eyes, contributing to a more
refreshed look overall. Outside the United States clinicians have begun
performing Ultherapy using a “dual plane” approach to create significant
improvements in the lower face and neck. In one procedure patients are treated
at two different depths, affecting twice the volume of tissue. Unlike other
energy-based treatments used for skin tightening, Ulthera’s non-invasive
approach is yielding consistent, significant changes.

Extensive pre-clinical studies were conducted at multiple sites beginning in
2004. Subsequent patient clinical trials beginning in 2006, consisting of
full-face procedures, yielded safe, reproducible and clinically significant
lift with no recuperation time.

“Ultherapy represents a new category of treatment that strikes a noteworthy
blend of both safety and effectiveness,” said Matt Likens, President and CEO
of Ulthera. “We are excited that our safe, non-invasive procedure has produced
such reliable results. The eyebrow lift indication is just the first of a
multitude of cosmetic and medical indications the Company will pursue for this
platform technology.”

The Company received its CE Mark in 2008 and began commercialization
activities outside the U.S. late last year. Health Canada clearance was
achieved on May 6, 2009, and Ulthera currently markets the Ulthera(TM) System
in Canada, Australia, Asia, Europe and the Middle East. FDA clearance
qualifies the System for sale in additional key aesthetics markets such as
South Korea, Thailand, Taiwan and others.

Ulthera will be marketing the Ulthera System directly to dermatologists,
plastic surgeons and facial plastic surgeons in the U.S., while partnering
with a network of international distributors outside the U.S. The measured
roll-out of the system will be accompanied by comprehensive technical and
clinical support to ensure the highest standard of customer and patient

About Ulthera

Ulthera, Inc. develops and markets innovative medical devices that leverage
the proven power and safety of ultrasound for rejuvenation of the skin and its
support structures. Treatment with the Ulthera System enables dermatologists,
plastic surgeons and facial plastic surgeons, for the first time, to
non-invasively see and treat at prescribed depths below the skin’s surface,
resulting in significant, reliable outcomes. Ulthera’s technologies and
clinical standards meet or exceed all FDA benchmarks for safety and
effectiveness, and are rooted in rigorous, ongoing clinical and scientific

Ulthera is privately held and headquartered in Mesa, Arizona. It was founded
in 2004 and was the first company to be spun off from Guided Therapy Systems,
LLC, a Mesa, Arizona-based ultrasonic medical technologies company. Ulthera is
supported by venture capital funding provided by New Enterprise Associates
(NEA) in the U.S. and Apposite Capital LLP., from the UK. For more
information, please visit

    Media Contact:

    Cheryl Pellegrino
    Zeno Group for Ulthera

To view the Multimedia News Release, go to:

SOURCE:  Ulthera, Inc. and

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